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Neuromuscular Disorders Clinical Trials

RESTORE: A Clinical Study of Patients with Symptomatic Neurogenic Orthostatic Hypotension to Assess Sustained Effects of Droxidopa Therapy

Aims: The purpose of this study is to evaluate the durability, effectiveness and safety of the study drug, droxidopa, in those with neurogenic orthostatic hypotension (NOH). Droxidopa (NORTHERA) has been approved in the United States for treatment of NOH. However, effectiveness beyond 2 weeks has not been demonstrated. This study is placebo-controlled to assess the benefits beyond 2 weeks and is therefore investigational. Total study participation can be up to 36 weeks.
Principal Investigator: Alexandru Barboi, MD
NorthShore Project Number: EH18-106
Contact: Please call 847.503.4334 with questions regarding the study
Open to Enrollment: Yes

Theravance Protocol 0169: A Phase III, 4-week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure
Aims: The objective of the study is to evaluate the efficacy of the study medication ampreloxetine (TD-9855) in subjects with multiple system atrophy (MSA), Parkinson’s disease (PD), or pure autonomic failure (PAF) experiencing symptomatic neurogenic orthostatic hypotension (snOH) compared with placebo at Week 4, as measured by the change from baseline of the Orthostatic Hypotension Symptom Assessment and other. Additional objectives include evaluation of the efficacy of TD-9855 in preventing incidence of falls and evaluation of the safety and tolerability of TD-9855.
Principal Investigator: Alexandru Barboi, MD
NorthShore Project Number: EH19-229
Contact: Please call 847.503.4334 with questions regarding the study

Theravance Protocol 0170: A Phase III, 4-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure
Aims: The primary objectives of the study are to evaluate the durability of effect of the study medication ampreloxetine (TD-9855) in subjects with symptomatic neurogenic orthostatic hypotension (snOH) due to multiple system atrophy (MSA), Parkinson’s disease (PD), or pure autonomic failure (PAF) compared with placebo over a double-blind, randomized withdrawal period of 6 weeks following an open label treatment of 16 weeks. The study also aims to evaluate the safety and tolerability of TD-9855 when taken for up to 22 weeks.
Principal Investigator: Alexandru Barboi, MD
NorthShore Project Number: EH19-232
Contact: Please call 847.503.4334 with questions regarding the study
Open to Enrollment: Yes

Theravance Protocol 0171: A Phase III, 182-Week, Open-Label, Safety and Tolerability Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension (snOH) in Subjects with Primary Autonomic Failure
Aims: The primary objective of the study is to evaluate the long-term safety of the study medication ampreloxetine (TD-9855) over a 182-week period. This study will also assess patient-reported quality of life outcomes.
Principal Investigator: Alexandru Barboi, MD
NorthShore Project Number: EH20-088
Contact: Please call 847.503.4334 with questions regarding the study

RAISE:  A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects with Generalized Myasthenia Gravis
Aims: the purpose of this research study is to determine the efficacy, safety and tolerability of Zilucoplan in subjects with Generalized Myasthenia Gravis. Zilucoplan is designed to work by preventing the body’s attack on neuromuscular junctions by blocking a component of the body's immune system called the complement system. Participants will be randomized at a 1:1 ratio. Zilucoplan will be supplied to the patient in 1mL prefilled syringes, to be self-administered by the participant daily.
Principal Investigator: Alexandru Barboi, MD
NorthShore Project Number: EH21-109
Contact: Please call 847.503.4334 with questions regarding the study
Open to Enrollment: Yes

Synuclein-One Study
Aims: the purpose of this research study is to determine whether small skin biopsies can be used as a novel method of detecting diseases collectively known as synucleinopathies which include Parkinson disease (PD), Multiple System Atrophy (MSA), Dementia with Lewy bodies and Pure Autonomic Failure (PAF). This study will evaluate the effectiveness of this skin biopsy test to confirm a diagnosis of a synucleinopathy and ensure that testing abnormalities are not detected in healthy individuals.
Principal Investigator: Alexandru Barboi, MD
NorthShore Project Number: EH21-081
Contact: Please call 847.503.4334 with questions regarding the study
Open to Enrollment: Yes